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Therefore, this product cannot be considered a drug as defined in section 201(g)(1) of the Act, 21 U.S.C

Semax and Dihexa belong to this category of brain-supporting peptides

And if a pharmaceutical company chooses to produce it again, it could apply for FDA approval through an abbreviated drug application since it was previously approved

These preclinical results led to a clinical trial in chronic lymphocytic leukemia (CLL), where chlorambucil-resistant patients achieved further remission through ethacrynic acid cotreatment with the alkylating agent (Petrini et al ., 1993)